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Endoscopic vs Surgical Gastrojejunostomy for Gastric Outlet Obstruction (EAT-GO Trial)

N/A
Recruiting
Led By Petros Benias, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new technique to treat patients with gastric outlet obstruction (GOO) caused by cancer. The new technique is less invasive and may improve quality of life for these patients.

Who is the study for?
Adults over 18 with unresectable or metastatic periampullary malignancies or distal gastric cancer causing severe gastric outlet obstruction. They must be able to undergo general anesthesia, have a life expectancy of more than 2 months, and cannot eat solids (GOOSS Score of 0 or 1). Not eligible if they have abdominal ascites, other GI tract strictures, previous related surgeries, are pregnant, under 18, or can't complete quality of life surveys.
What is being tested?
This study is testing two ways to treat blockages at the stomach exit: one group will receive an endoscopic gastrojejunostomy (EGJ), which is less invasive and done through the mouth; another group will get a surgical gastrojejunostomy (SGJ), which involves surgery on the belly. Patients are randomly assigned to either method.
What are the potential side effects?
Possible side effects for both procedures include pain at the intervention site, infection risk from surgery or scope insertion, bleeding complications, potential injury to surrounding organs during procedure and post-operative digestive issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to initiation of solid oral intake without symptoms of GOO
Secondary study objectives
Change in BMI
Change in Gastric Outlet Obstruction Symptom Score (GOOSS)
Change in Gut Function Score (GFS)
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Endoscopic gastrojejunostomy (EGJ)Experimental Treatment1 Intervention
A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure.
Group II: Surgical gastrojejunostomy (SGJ)Active Control1 Intervention
An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,128 Total Patients Enrolled
Petros Benias, MDPrincipal InvestigatorNorthwell Health
1 Previous Clinical Trials
4 Total Patients Enrolled
Arvind Trindade, MDPrincipal InvestigatorNorthwell Health
2 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Endoscopic gastrojejunostomy (EGJ) Clinical Trial Eligibility Overview. Trial Name: NCT05561907 — N/A
Gastric Outlet Obstruction Research Study Groups: Surgical gastrojejunostomy (SGJ), Endoscopic gastrojejunostomy (EGJ)
Gastric Outlet Obstruction Clinical Trial 2023: Endoscopic gastrojejunostomy (EGJ) Highlights & Side Effects. Trial Name: NCT05561907 — N/A
Endoscopic gastrojejunostomy (EGJ) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05561907 — N/A
~10 spots leftby Dec 2025
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